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Author: Jean-Claude Muller, 穆卓Executive Editor at BtoBioInnovation  jcm9144@gmail.com

SPECIAL REPORT #35

Resurrection of Biogen’s and Eisai’s Aducanumab?

Earlier this week, Biogen and partner Eisai have announced that they will file a Biologics License Agreement (BLA) at the US FDA, early next year, for aducanamab, an amyloid-targeting monoclonal antibody, as a new treatment for Alzheimer’s disease.  The announcement comes as a major surprise to all analysts, just months after both companies had indicated that the development of the drug had been stopped after the failure of a futility analysis. In a note titled “Shocking, simply shocking”, J.P. Morgan’s analyst Corey Kasimob wrote “We are left somehow speechless by news this morning that Biogen’s Alzheimer’s drug candidate aducanumab is back from the dead”. In making its case, Biogen argued that the futility analysis was based on a smaller data set that featured fewer patients who received a high-dose of aducanumab. Adding the additional data, aducanumab showed statistically significant changes on clinical dementia scale with the highest dose and still supports the validity of the anti-amyloid hypothesis. “The result of the futility was incorrect” wrote Biogen in a presentation where it shared some of the evidence it had gathered in the expanded data set for one of the phase 3 trials EMERGE. We do not consider ourselves as sufficiently expert in the field to make a relevant assessment on our own and explain the better results seen in the various subsets of ENGAGE patients and the EMERGE trials. Many analysts are now very eager to see how the US FDA will handle the aducanumab case. Will there be the call of an advisory board? Will the FDA, possibly with a new Commissioner, approve a new medicine based on some unconventional evidence falling short of usual standards, because the drug targets a major unmet medical need?

Biogen shares rose by 30% just after the announcement. Adacunamab is now valued at 0 or $12 billion and has the potential to complete change the profile of the company.

October 27, 2019

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